Healthy Volunteer StudyPhase 1FIMPAMNCT02393950
Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers
A Phase 1 study testing ODM-106 in people with Healthy Volunteer Study, run by Orion Corporation, Orion Pharma at 1 site in Germany.
Trial summary
The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- ODM-106
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent obtained.
- Participants must be able to speak, read and understand German.
- Good general health ascertained by detailed medical history and physical examinations.
- Males 18-45 years (inclusive).
- Body mass index (BMI) 18-30 kg/m2 inclusive
- Weight 55-95 kg (inclusive).
- Participants with female partners of child-bearing potential must adhere to a proper form of contraception from first study treatment administration until 3 months after the end-of-study visit.
Who cannot join
- A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or communicate well with the investigator.
- Vulnerable subjects.
- Veins unsuitable for repeated venipuncture.
- Evidence of clinically relevant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator. The participants should be healthy subjects.
- Subjects with a medical history of relevant psychiatric disorders or evidence of significant neuropsychiatric disease
- Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study.
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- Definite or suspected personal history of hypersensitivity to drugs or excipients.
- Intake of any medication that could affect the outcome of the study, as judged by the investigator, within 2 weeks before first study treatment administration (2 months for enzyme inducing drugs like rifampicin or carbamazepin), or less than 5 times the half-life of the medication.
- A history of alcoholism or excess alcohol intake (including regular consumption of more than 21 units of alcohol per week) .
- Use of nicotine-containing products within 6 months of admission and inability to refrain from using nicotine-containing products during the study.
- History of drug abuse or positive drug screen for amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, methamphetamine or methadone.
- Propensity to get headache when refraining from caffeine-containing beverages.
- Blood donation or loss of clinically relevant amount of blood within 2 months before the screening visit.
- Abnormal 12-lead ECG finding of clinical relevance at the screening visit
- Heart rate (HR) < 50 bpm or > 90 bpm after 10 min in rest (supine) at the screening visit
- At the screening visit: systolic BP < 90 mmHg or > 140 mmHg, diastolic BP < 50 mmHg or > 90 mmHg, orthostatic hypotension decrease of greater than or equal to 20 mmHg for systolic BP, decrease of greater than or equal to 10 mmHg for diastolic BP.
- Abnormal 24-h Holter of clinical relevance at the screening visit,
- Positive serology to human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies.
- Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part in the study.
- Participation in an investigational drug study within 2 months before entry into this study.
- An employee, a direct or indirect relative of the employee of the contract research organisation or the sponsor.
- Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the subject.
- Subject with abnormal standard EEG judged as clinically relevant by the investigator at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single Escalating Doses of ODM-106: A Randomised, Double-blind, Placebo-controlled Single Centre Study in Healthy Males
The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.
Read the detailed description
Eight planned dose levels of ODM-106 will be compared with placebo.There will be 2 panels of subjects with 4 dose levels in each panel. Subjects will be randomised to receive 3 dose levels of active treatment (single doses) and 1 dose of placebo. The dose levels will be escalated from the smallest dose upwards within the study and within the study subject. A third panel of 8 subjects may be included to investigate further dose levels of ODM-106, investigate the effect of taking ODM-106 with food or to compare two different formulations of ODM-106. For an individual subject, the study will consist of a screening period (maximum 4 weeks), 4 study treatment periods with a wash-out period between each study treatment administration and a post-treatment period of about 2 weeks.
The study duration for an individual will be approximately 12-16 weeks. Blood samples will be collected for the assessment of the concentration of ODM-106 and its metabolite.Plasma samples and cumulative urinary samples will be collected for metabolite screening. Safety will be assessed by a 12-lead electrocardiogram (ECG), continuous ECG monitoring, Holter ECG, supine and orthostatic blood pressure and heart rate, body temperature, physical examination, electroencephalogram (EEG), laboratory safety assessments and adverse events. Sedation and psychomotor tests and a quantitative EEG will also be performed.
- Conditions
- Healthy Volunteer Study
- Being tested
- ODM-106, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-106Drug
Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.
PlaceboDrug
Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Drug: ODM-106 | Experimental | Oral capsules dosage 2-800mg once daily for one day Receives: Drug: ODM-106 |
| Drug: Placebo | Placebo comparator | Oral capsules given once daily for one day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.
Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.
Measured: From screening up to 16 weeks
Secondary outcomes (9)
Peak Plasma Concentration (cMax) of ODM-106
cMax of ODM-106 after single dosing of either Capsule B or Capsule A
Measured: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.
Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106
AUC of ODM-106 after single oral dosing of either Capsule B or Capsule A.
Measured: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level
Time to Peak Plasma Concentration (Tmax) of ODM-106
tmax of ODM-106 after single oral dosing of Capsule B or Capsule A
Measured: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level
Elimination Half-life of ODM-106
Elimination half-life of ODM-106 after single dosing of either Capsule B or Capsule A
Measured: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.
Metabolite Screening in Plasma and Urine
Metabolite screening in plasma and urine after single dosing
Measured: Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level
Effect of ODM-106 on Growth Hormone Levels
Growth hormone levels (Cmax) in serum after single oral dosing with either ODM-106 Capsule B, ODM-106 Capsule A or placebo.
Measured: Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.
Sedation Scores on a Visual Analogue Scale (VAS)
Assessment of sedation by subject
Measured: Pre-dose and at 1, 6 and 10.5h post dose at each dose level
Dexterity and Reaction Times
Selected battery of psychomotor tests
Measured: Pre-dose and at 1 and 6h post dose at each dose level
Quantitative EEG
Quantitative analysis of EEG
Measured: Pre-dose and at 1, 6 and 10 h post dose at each dose level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainard Fuhr, MD, Principal investigator, Parexel International GmbH, Berlin, GermanyJohn Whiteside, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393950
- Sponsor's protocol ID
- 3117001
- Other IDs
- 2014-001317-33, 2014
- Acronym
- FIMPAM
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2015
- Last updated
- 23 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single Escalating Doses of ODM-106: A Randomised, Double-blind, Placebo-controlled Single Centre Study in Healthy Males
- ClinicalTrials.gov ID
- NCT02393950
- Acronym / sponsor ID
- FIMPAM / 3117001
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 23 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.
Detailed description
Eight planned dose levels of ODM-106 will be compared with placebo.There will be 2 panels of subjects with 4 dose levels in each panel. Subjects will be randomised to receive 3 dose levels of active treatment (single doses) and 1 dose of placebo. The dose levels will be escalated from the smallest dose upwards within the study and within the study subject. A third panel of 8 subjects may be included to investigate further dose levels of ODM-106, investigate the effect of taking ODM-106 with food or to compare two different formulations of ODM-106. For an individual subject, the study will consist of a screening period (maximum 4 weeks), 4 study treatment periods with a wash-out period between each study treatment administration and a post-treatment period of about 2 weeks.
The study duration for an individual will be approximately 12-16 weeks. Blood samples will be collected for the assessment of the concentration of ODM-106 and its metabolite.Plasma samples and cumulative urinary samples will be collected for metabolite screening. Safety will be assessed by a 12-lead electrocardiogram (ECG), continuous ECG monitoring, Holter ECG, supine and orthostatic blood pressure and heart rate, body temperature, physical examination, electroencephalogram (EEG), laboratory safety assessments and adverse events. Sedation and psychomotor tests and a quantitative EEG will also be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: ODM-106 | Experimental | Drug: ODM-106Oral capsules dosage 2-800mg once daily for one day |
| Drug: Placebo | Placebo comparator | Drug: PlaceboOral capsules given once daily for one day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent obtained.
- Participants must be able to speak, read and understand German.
- Good general health ascertained by detailed medical history and physical examinations.
- Males 18-45 years (inclusive).
- Body mass index (BMI) 18-30 kg/m2 inclusive
Key exclusion criteria (23 listed)
- A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or communicate well with the investigator.
- Vulnerable subjects.
- Veins unsuitable for repeated venipuncture.
- Evidence of clinically relevant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator. The participants should be healthy subjects.
- Subjects with a medical history of relevant psychiatric disorders or evidence of significant neuropsychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODM-106Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo. | Drug | Drug: ODM-106 |
| PlaceboSingle oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo. | Drug | Drug: Placebo |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.
Time frame: From screening up to 16 weeks
Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.
9 secondary outcomes
Peak Plasma Concentration (cMax) of ODM-106
Time frame: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.
Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106
Time frame: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level
Time to Peak Plasma Concentration (Tmax) of ODM-106
Time frame: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level
Elimination Half-life of ODM-106
Time frame: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.
Metabolite Screening in Plasma and Urine
Time frame: Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level
Effect of ODM-106 on Growth Hormone Levels
Time frame: Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.
Sedation Scores on a Visual Analogue Scale (VAS)
Time frame: Pre-dose and at 1, 6 and 10.5h post dose at each dose level
Dexterity and Reaction Times
Time frame: Pre-dose and at 1 and 6h post dose at each dose level
Quantitative EEG
Time frame: Pre-dose and at 1, 6 and 10 h post dose at each dose level
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainard Fuhr, MD principal investigator
Parexel International GmbH, Berlin, Germany
John Whiteside study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ODM-106 in people with Healthy Volunteer Study, run by Orion Corporation, Orion Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability. (time frame: From screening up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.